IYN · Class II · 21 CFR 892.1550

FDA Product Code IYN: System, Imaging, Pulsed Doppler, Ultrasonic

FDA product code IYN covers pulsed Doppler ultrasonic imaging systems.

These devices use pulsed-wave Doppler technology to measure blood flow velocity and visualize vascular structures in real time. They are widely used in cardiology, obstetrics, and vascular diagnostics.

IYN devices are Class II medical devices, regulated under 21 CFR 892.1550 and reviewed by the FDA Radiology panel.

Leading manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Siemens Medical Solutions USA, Inc. and Samsung Medison Co., Ltd..

1185
Total
1185
Cleared
94d
Avg days
1978
Since
1185 devices
1033–1056 of 1185
Cleared Apr 08, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
K013848
U-Systems, Inc.
Radiology · 139d
Cleared Apr 04, 2002
GE VIVID 3 EXPERT
K020789
General Electric Co.
Radiology · 24d
Cleared Feb 13, 2002
OMNIA X/XS ULTRASOUND SYSTEM
K020353
Siemens Medical Systems, Inc.
Radiology · 9d
Cleared Feb 11, 2002
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
K013722
Hitachi Medical Corp.
Radiology · 94d
Cleared Feb 06, 2002
LOGIQ 3
K020263
General Electric Co.
Radiology · 12d
Cleared Jan 10, 2002
GE LOGIQ 5
K014097
GE Medical Systems
Radiology · 29d
Cleared Jan 07, 2002
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
K014191
Philips Medical Systems
Radiology · 17d
Cleared Dec 20, 2001
HAND-CARRIED ULTRASOUND SYSTEM
K014116
Sonosite,Inc.
Radiology · 6d
Cleared Nov 16, 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
K013627
Medison America, Inc.
Radiology · 11d
Cleared Sep 12, 2001
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K012867
Medison America, Inc.
Radiology · 16d
Cleared Aug 29, 2001
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
K012080
Aloka Co., Ltd.
Radiology · 57d
Cleared Aug 10, 2001
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER
K012239
Hitachi Medical Corp.
Radiology · 24d
Cleared Aug 10, 2001
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
K012369
Atys Medical
Radiology · 15d
Cleared Jul 26, 2001
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES
K012191
Teratech Corp.
Radiology · 13d
Cleared May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457
Aloka Co., Ltd.
Radiology · 12d
Cleared May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
K011188
GE Medical Systems
Radiology · 30d
Cleared May 15, 2001
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
K011315
Aloka Co., Ltd.
Radiology · 15d
Cleared May 04, 2001
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
K011224
Advanced Technology Laboratories, Inc.
Radiology · 14d
Cleared Apr 03, 2001
ULTRASOUND SCANNER TYPE 2102
K003986
B & K Medical A/S
Radiology · 98d
Cleared Mar 20, 2001
EXHALE DOPPLER SYSTEM
K010649
Broncus Technologies, Inc.
Radiology · 15d
Cleared Mar 15, 2001
NEMIO
K010631
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Mar 13, 2001
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
K010405
Biosound Esaote, Inc.
Radiology · 29d
Cleared Mar 01, 2001
LOGIQ 500
K010329
General Electric Co.
Radiology · 27d
Cleared Feb 21, 2001
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K010374
Sonosite,Inc.
Radiology · 14d